PENG Block forTranscatheter Aortic Valve Implantation

NCT05904912 | Completed

• 1 other identifier: Medipol Hospital 32
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.

Conditions

Aortic Valve Stenosis; Aortic Diseases

Keywords

Aortic valve stenosis; Transcatheter aortic valv implantation (TAVI); PENG block; Postoperative analgesia management

Outcome Measures

Primary Outcomes (1)

• The need for fentanyl during the procedure

  Intraoperative additional fentanyl need and dosage will be recorded

  Intraoperative period

Secondary Outcomes (3)

• Quadriceps muscle strength

  Postoperative 24 hours period

• The use of rescue analgesia

  Postoperative 24 hours period]

• Pain scores (Numerical Rating Scale-NRS)

  Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours

Study Arms (2)

Group PENG = PENG block

ACTIVE COMPARATOR

PENG block will be performed

Drug: Postoperative analgesia management; Drug: PENG-Bupivacaine

Group C = Control group

OTHER

Local infiltration will be applied.

Drug: Postoperative analgesia management; Drug: Local infiltration-Bupivacaine

Interventions

Postoperative analgesia management DRUG

Intravenous 0.5 mg/kg tramodol and 1 gr paracetamol will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered iparacetamol iv 1 gr 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.

Group C = Control group; Group PENG = PENG block

PENG-Bupivacaine DRUG

The probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process, and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block area is confirmed with 5 ml of saline, 30 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.

Group PENG = PENG block

Local infiltration-Bupivacaine DRUG

Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team

Group C = Control group

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ASA classification I-III,
• Aged 20-80 years
• Who will be scheduled for TAVI.

You may not qualify if:

• Patients who have a history of bleeding diathesis,
• Take anticoagulant therapy,
• History of chronic pain before surgery,
• Multiple trauma,
• Who cannot assess their pain (dementia),
• Who have been operated under spinal or epidural anesthesia,
• Who have an infection in the area and do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (5)

• Clayton B, Morgan-Hughes G, Roobottom C. Transcatheter aortic valve insertion (TAVI): a review. Br J Radiol. 2014 Jan;87(1033):20130595. doi: 10.1259/bjr.20130595. Epub 2013 Nov 20.

  PMID: 24258463 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available.

  PMID: 31212123 BACKGROUND

• Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.

  PMID: 34175637 BACKGROUND

• Gul YG, Alver S, Ozen V, Golboyu BE, Ciftci B. Pericapsular nerve group block reduces fentanyl use in transcatheter aortic valve implantation: a randomized prospective study. Clin Res Cardiol. 2025 Nov 24. doi: 10.1007/s00392-025-02815-0. Online ahead of print.

  PMID: 41284052 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant will be blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: Sixty patients aged 20-95 years old with American Society of Anesthesiologists (ASA) classification I-IV and scheduled for TAVI will be included in the study. Patients will be randomly divided into two groups (Group PENG = PENG block group, Group Control = local infiltration group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: June 10, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)